Top 16 Regulatory affairs Jobs in St. Louis, Mo

Regulatory Affairs Specialist
Curium Pharma —St. Louis, MO
- Overtime
- Mid-level
- Office
- 3 years
Regulatory Affairs Specialist
Spectrum Brands —St. Louis, MO
- Full-time
- Hybrid work
- Bachelor of Science
- Mid-level
- Office
Quick Apply
5d
Senior Regulatory Affairs Specialist
Curium Pharma —St. Louis, MO
- Overtime
- 5 years
- Mid-level
- Office
Regulatory Specialist
Elemental Enzymes —St. Louis, MO
- Online Application
- Microsoft Excel
- Laboratory experience
- Mid-level
- Health savings account
- Disability insurance
Quick Apply
9d
Principle Scientist - Regulatory Toxicology
Bayer —Chesterfield, MO
- $114,640 - $170,000 a year
- 5 years
- Laboratory experience
- Doctor of Philosophy
- Health insurance
- Dental insurance
4d
Senior Regulatory Affairs Specialist - Global Pet Care
Spectrum Brands —Earth City, MO
- Full-time
- Hybrid work
- Bachelor of Science
- Mid-level
- 3 years
- Work from home
Quick Apply
Clinical Trial Assistant
EVERSANA —Chesterfield, MO
- Full-time
- Office
- High school diploma or GED
- Travel
Quick Apply
Policy Analyst
MANTECH —St. Louis, MO
- Full-time
- Computer Science
- Office
- Bachelor's degree
Compliance Specialist
Stratus Estate Buyers —Olivette, MO
- Full-time
- Background check
- Office
- Fingerprint clearance
- Health savings account
- Health insurance
Quick Apply
2d
Director, Global Regulatory Lead
Curium Pharma —St. Louis, MO
- Bachelor's degree
- Doctor of Philosophy
- Senior level
Senior Project Manager
Curium Pharma —St. Louis, MO
- Weekends as needed
- Microsoft Word
- Microsoft Excel
- 5 years
Strategic Initiatives Officer Mid
Tulk LLC —St. Louis, MO
- $124,000 - $148,800 a year
- Full-time
- 7 years
- Office
- Databases
- Disability insurance
- Health insurance
Quick Apply
Associate Director, Health IT
TSP (A Syneos Health Company) —St. Louis, MO
- $140,000 - $180,000 a year
- 5 years
- Analysis skills
- Bachelor's degree
- Health insurance
- Dental insurance
Senior Medical Science Liaison (KS, MO, OK, AR)
Summit Therapeutics —St. Louis, MO
- $200,000 - $235,000 a year
- Medicine
- Doctor of Philosophy
- Travel
Quick Apply
Associate Director of Clinical Research (IIT & Program Strategy Focus) - Radiation Oncology
Washington University in St. Louis —St. Louis, MO
- $84,200 - $148,500 a year
- Online Application
- Nursing
- RN License
- Pass drug screening
- Commuter assistance
- Employee assistance program

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Regulatory Affairs Specialist
Curium Pharma —St. Louis, MO
Minimum of 3 years of Regulatory experience or related field. Cross-functional interaction experience, coordinating activities, driving projects and initiatives…
Regulatory Affairs Specialist
Spectrum Brands —St. Louis, MO
1+ years of experience in a regulated field or technical discipline. B.S. or B.A. in science or related field.
Quick Apply
5d

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Regulatory Affairs Specialist

Curium Pharma -
St. Louis, MO

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Job Details

Qualifications

Project team coordination
Document viewing software
Cross-functional collaboration
Adobe Acrobat
Cross-functional communication

Full Job Description

About Curium

Curium is the world’s largest nuclear medicine company with more than a century of industry experience. We develop, manufacture and distribute world-class radiopharmaceutical products to help patients around the globe. Our proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence and unparalleled service.

With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life-threatening diseases to over 14 million patients annually. The name ‘Curium’ honors the legacy of pioneering radioactive researchers Marie and Pierre Curie, after whom the radioactive element curium was named and emphasizes our focus on nuclear medicine. The tagline ‘Life Forward’ represents our commitment to securing a brighter future for all those we serve: An enhanced quality of care for our patients. A trusted partner to our customers. A supportive employer to our valued team.

Summary of Position

The Regulatory Affairs Product Specialist responsibilities encompass the support of US FDA applications (NDAs, ANDAs, DMFs) and international drug product applications. Support of Regulatory activities including but not limited to:

Plan/author/compile/submit statutory reports in eCTD format for marketed products per FDA requirements
Review and assess CMC regulatory impact of post-approval changes proposed at the manufacturing site and provide regulatory strategy
Plan/author/compile/submit/manage variations and supplements for marketed products within and outside the United States
Participate in cross-functional teams and provide health authority requirements needed for support of post-approval changes
Author/review updates to marketed product labeling
Maintain regulatory knowledge of current guidelines and regulations
Maintain current regulatory databases and produce various reports as needed
Utilize and support electronic document management system
Provide mentorship for entry-level regulatory associates

Work schedule: Monday – Friday 8am – 5pm

Essential Functions

Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).
Authoring, organization, and preparation of electronic (eCTD) regulatory filings; also includes peer review of filings
Understand and identify potential regulatory risks and recommended strategies based on current FDA/health authority requirements
Manage multiple priorities
Attend necessary trainings and seminars to keep abreast of new and/or changes in the Regulatory profession.
Critically review documentation for regulatory submissions and provide input for necessary revisions.

Requirements

Bachelor Degree in scientific discipline required or equivalent work experience.
Minimum of 3 years of Regulatory experience or related field.
Cross-functional interaction experience, coordinating activities, driving projects and initiatives to completion, and working to align communications with other departments is required.
Project leadership experience is preferred.
Strong organizational skills, strong attention to detail, ability to problem solve and to work well with others and cross-functionally.
Excellent written and oral communication skills.
Use of change controls software system.
Strong background using Microsoft Office tools and Adobe Acrobat.

Working Conditions:

Standard office environment.
Willingness to work in a team-based environment.
Close attention to detail required.
May be required to sit or stand for long periods of 8+ hours a day while performing duties.
The position deals with many deadlines. Due to the short turnaround time of deadlines and limited time, overtime, weekend work and holiday work is sometimes required.

Disclaimer

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

Equal Opportunity Employer

Curium is an equal opportunity employer and believes everyone deserves respect, dignity and equality. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

Apply Now

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regulatory affairs jobs in st. louis, mo

Regulatory Affairs Specialist

Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist

Regulatory Specialist

Principle Scientist - Regulatory Toxicology

Senior Regulatory Affairs Specialist - Global Pet Care

Clinical Trial Assistant

Policy Analyst

Compliance Specialist

Director, Global Regulatory Lead

Senior Project Manager

Strategic Initiatives Officer Mid

Associate Director, Health IT

Senior Medical Science Liaison (KS, MO, OK, AR)

Associate Director of Clinical Research (IIT & Program Strategy Focus) - Radiation Oncology

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